efficacy and safety of glecaprevir/pibrentasvir (abt-493/abt-530) in treatment-naive and treatment-experienced asian adults with chronic hepatitis c virus genotype (gt) 1 to gt6 infection with compensated cirrhosis and with or without human immunodeficiency virus co-infection

Conditions: Hepatitis C Virus (HCV)

Summary: this study will evaluate the efficacy and safety of glecaprevir/pibrentasvir (abt-493/abt-530) in chronic hepatitis c virus (hcv) genotype (gt)1 to gt6-infected asian participants with compensated cirrhosis with or without human immunodeficiency virus (hiv) co-infection who are hcv treatment-naïve or treatment-experienced with interferon (ifn) (alpha, beta or pegylated interferon \[pegifn\]) with or without ribavirin (rbv) or sofosbuvir with rbv with or without ifn.


Eligibility criteria:
inclusion criteria: * must be of asian descent. * screening laboratory result indicating hepatitis c virus (hcv) genotype (gt) 1, 2, 3, 4, 5 or 6 infection. * positive anti-hcv antibody (ab) and hcv ribonucleic acid (rna) greater than or equal to 1000 iu/ ml at screening visit. * chronic hcv infection defined as one of the following: * positive for anti-hcv ab or hcv rna at least 6 months before screening; or * a liver biopsy consistent with chronic hcv infection; * hcv treatment-naïve to any approved or investigational hcv treatment or treatment-experienced with interferon (ifn) (alpha, beta or pegylated interferon \[pegifn\] with or without ribavirin (rbv) or sofosbuvir with rbv with or without ifn. previous treatment must have been completed \>= 8 weeks prior to screening. * compensated cirrhosis defined as child-pugh score of ≤ 6 at screening and no current or past clinical evidence of child-pugh b or c classification or clinical history of liver decompensation including ascites noted on physical exam, bleeding varices, use of diuretics for ascites, or hepatic encephalopathy. * absence of hepatocellular carcinoma (hcc) participants enrolled with human immunodeficiency virus (hiv)-1 and hcv co-infection must also meet the following criteria: * positive test result for human immunodeficiency virus antibody (hiv ab) at screening. * naïve to treatment with any antiretroviral therapy (art) with a cluster of differentiation (cd)4+ count greater than or equal to 500 cells/mm³ (or cd4+ % \>= 29%), or * on a stable, qualifying hiv-1 art regimen with cd4+ count \>= 200 cells/mm³ (or cd4+ % \>= 14%) at screening; and plasma hiv-1 rna below lower limit of quantification (lloq) by an approved plasma hiv-1 rna quantitative assay at screening and at least once during the 12 months prior to screening. exclusion criteria: * positive test result for hepatitis b surface antigen (hbsag) or positive test result for hepatitis b virus (hbv) deoxyribonucleic acid (dna) if hbsag is negative. * any cause of liver disease other than chronic hcv-infection. * hcv genotype performed during screening indicating co-infection with more than one hcv genotype * clinically significant abnormalities, other than hcv infection or hcv/hiv co-infection * chronic human immunodeficiency virus, type 2 (hiv-2) infection additional exclusion criteria for participants with hcv/hiv co-infection: * for participants on stable art, taking anti-retroviral agent(s) other than those permitted * treatment for an acquired immunodeficiency syndrome (aids)-associated opportunistic infection within 12 months of screening or prophylaxis for an aids-associated opportunistic infection within 6 months of screening * diagnosis of any clinical aids-defining event within 12 months prior to screening.

Keywords: chronic hepatitis c virus (hcv) genotype 1 to 6 cirrhosis compensated cirrhosis human immunodeficiency virus co-infection treatment-naïve treatment-experienced interferon asian